Healthy Volunteers
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to evaluate the effect of vortioxetine (10 and 20 mg, once daily) versus paroxetine (20 mg, once daily) on sexual functioning in healthy participants after 5 weeks of double-blind treatment.
Detailed description
The drug being tested in this study is called vortioxetine. This study will look at the effect of treatment on sexual functioning in healthy participants. The study will enroll approximately 352 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Vortioxetine 10 mg * Vortioxetine 20 mg * Paroxetine 20 mg * Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient All participants will be asked to take one tablet/capsule, daily, orally for up to 5 weeks. This multicenter trial will be conducted in United States. The overall time to participate in this study is approximately 7 weeks. Participants will be contacted by telephone 2 weeks after last dose of study drug for a follow-up assessment.
Interventions
DRUGVortioxetine
Vortioxetine Overencapsulated Tablet
DRUGParoxetine
Paroxetine Overencapsulated Tablets.
DRUGPlacebo
Vortioxetine Placebo-matching Capsules.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is sexually active and has been in a steady relationship and plans to remain in that relationship for the duration of the study. 2. Has a body mass index (BMI) of 18 to 35 kg/m\^2, inclusive, at the Screening and Baseline Visits. 3. If female, has a regular menstrual cycle. 4. Has normal sexual functioning, as defined by a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score \>47 (men) or \>41 (women) at the Screening and Baseline Visits. 5. If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months prior to the Baseline Visit and continues on the stable dose for the duration of the study.
Exclusion criteria
1. Has received vortioxetine and/or paroxetine in a previous clinical study or as a therapeutic agent. 2. Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any known sexually transmitted diseases. 3. Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit. 4. Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit. 5. Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma. 6. Has a history of depression or any other psychiatric illness. 7. Has a significant risk of suicide according to the investigator's clinical judgment, or has made a suicide attempt in the previous 6 months. 8. Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual dysfunction. 9. Has had a surgical or medical procedure on reproductive/genitourinary organs (excluding uncomplicated vasectomy and tubal ligation). 10. If female, has polycystic ovarian syndrome. 11. Has hypogonadism or has a free testosterone value outside the normal range at the Screening Visit that is indicative of hypogonadism. 12. Has a thyroid-stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS) | Baseline and Week 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. |
| Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) | Baseline and Week 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. |
| Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) | Baseline and Week 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Weeks 1, 2, 3, 4 and 5 | Sexual dysfunction is defined as CSFQ-14 score ≤47 for men and ≤41 for women. |
| Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Baseline and Weeks 1, 2, 3 and 4 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. |
| Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Baseline and Weeks 1, 2, 3, 4 and 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the 3 phases of the sexual response cycle , desire (5 items, score range 5-25), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. |
| Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Baseline and Weeks 1, 2, 3, 4 and 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the subscales of pleasure (1 item, score range 1-5), desire/frequency (2 items, score range 2-10), desire/interest (3 items, score range 3-15), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. |
| Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Baseline and Weeks 1, 2, 3, 4 and 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. |
| Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Baseline and Weeks 1, 2, 3, 4 and 5 | The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 16 investigative sites in the United States from 21 November 2016 to 09 June 2017.
Pre-assignment details
Healthy volunteers were randomized in a 1:1:1:1 ratio to one of 4 treatment arms: vortioxetine 10 mg, vortioxetine 20 mg, paroxetine or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks. | 92 |
| Paroxetine 20 mg Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. | 85 |
| Vortioxetine 10 mg Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks. | 91 |
| Vortioxetine 20 mg Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks. | 93 |
| Total | 361 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 3 | 6 | 0 |
| Overall Study | Noncompliance with Study Drug | 2 | 3 | 3 | 4 |
| Overall Study | Pregnancy | 0 | 1 | 1 | 0 |
| Overall Study | Pretreatment Event/Adverse Event | 3 | 5 | 1 | 3 |
| Overall Study | Randomized But Not Treated | 1 | 1 | 0 | 2 |
| Overall Study | Reason not Specified | 1 | 0 | 2 | 2 |
| Overall Study | Significant Protocol Deviation | 2 | 3 | 6 | 1 |
| Overall Study | Study Termination | 0 | 1 | 0 | 0 |
| Overall Study | Voluntary Withdrawal | 2 | 1 | 4 | 2 |
Baseline characteristics
| Characteristic | Paroxetine 20 mg | Vortioxetine 10 mg | Placebo | Vortioxetine 20 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 28.9 years STANDARD_DEVIATION 5.96 | 28.1 years STANDARD_DEVIATION 5.56 | 27.8 years STANDARD_DEVIATION 5.45 | 28.8 years STANDARD_DEVIATION 5.91 | 28.4 years STANDARD_DEVIATION 5.72 |
| Body Mass Index (BMI) | 26.91 kg/m^2 STANDARD_DEVIATION 4.245 | 26.77 kg/m^2 STANDARD_DEVIATION 4.306 | 25.72 kg/m^2 STANDARD_DEVIATION 3.925 | 25.70 kg/m^2 STANDARD_DEVIATION 3.668 | 26.26 kg/m^2 STANDARD_DEVIATION 4.062 |
| Duration of Menstrual Cycle | 28.3 days STANDARD_DEVIATION 2.56 | 28.2 days STANDARD_DEVIATION 7.07 | 28.9 days STANDARD_DEVIATION 5.35 | 28.0 days STANDARD_DEVIATION 6.94 | 28.4 days STANDARD_DEVIATION 5.75 |
| Duration of Menstruation | 4.4 days STANDARD_DEVIATION 1.27 | 4.2 days STANDARD_DEVIATION 1.27 | 4.9 days STANDARD_DEVIATION 1.36 | 4.6 days STANDARD_DEVIATION 1.37 | 4.5 days STANDARD_DEVIATION 1.33 |
| Female Reproductive Status Female of childbearing potential | 38 Participants | 42 Participants | 43 Participants | 41 Participants | 164 Participants |
| Female Reproductive Status NA/Participant is male | 43 Participants | 47 Participants | 46 Participants | 49 Participants | 185 Participants |
| Female Reproductive Status Surgically sterile | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 12 Participants |
| Height | 172.1 cm STANDARD_DEVIATION 10.59 | 171.3 cm STANDARD_DEVIATION 9.14 | 172.0 cm STANDARD_DEVIATION 10.75 | 170.8 cm STANDARD_DEVIATION 10.04 | 171.5 cm STANDARD_DEVIATION 10.12 |
| Median Age Categories ≤ 28 Years | 43 Participants | 52 Participants | 51 Participants | 47 Participants | 193 Participants |
| Median Age Categories > 28 Years | 42 Participants | 39 Participants | 41 Participants | 46 Participants | 168 Participants |
| Race Categories Non-white | 36 Participants | 39 Participants | 41 Participants | 38 Participants | 154 Participants |
| Race Categories White | 49 Participants | 52 Participants | 51 Participants | 55 Participants | 207 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 7 Participants | 3 Participants | 15 Participants |
| Race/Ethnicity, Customized Black or African American | 29 Participants | 31 Participants | 30 Participants | 34 Participants | 124 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 20 Participants | 25 Participants | 21 Participants | 18 Participants | 84 Participants |
| Race/Ethnicity, Customized Multiracial | 3 Participants | 3 Participants | 4 Participants | 1 Participants | 11 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic and Latino | 65 Participants | 66 Participants | 71 Participants | 75 Participants | 277 Participants |
| Race/Ethnicity, Customized White | 49 Participants | 52 Participants | 51 Participants | 55 Participants | 207 Participants |
| Region of Enrollment United States | 85 Participants | 91 Participants | 92 Participants | 93 Participants | 361 Participants |
| Sex: Female, Male Female | 42 Participants | 44 Participants | 46 Participants | 44 Participants | 176 Participants |
| Sex: Female, Male Male | 43 Participants | 47 Participants | 46 Participants | 49 Participants | 185 Participants |
| Smoking Classification Participant has never smoked | 70 Participants | 70 Participants | 73 Participants | 77 Participants | 290 Participants |
| Smoking Classification Participant is a current smoker | 2 Participants | 4 Participants | 7 Participants | 7 Participants | 20 Participants |
| Smoking Classification Participant is an ex-smoker | 13 Participants | 17 Participants | 12 Participants | 9 Participants | 51 Participants |
| Weight | 80.19 kg STANDARD_DEVIATION 16.808 | 78.67 kg STANDARD_DEVIATION 14.85 | 76.49 kg STANDARD_DEVIATION 15.523 | 75.12 kg STANDARD_DEVIATION 13.282 | 77.56 kg STANDARD_DEVIATION 15.192 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 84 | 0 / 91 | 0 / 91 |
| other Total, other adverse events | 36 / 91 | 59 / 84 | 52 / 91 | 40 / 91 |
| serious Total, serious adverse events | 0 / 91 | 0 / 84 | 0 / 91 | 0 / 91 |
Outcome results
Primary
Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS)
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.
Time frame: Baseline and Week 5
Population: FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Paroxetine 20 mg | Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS) | Change from Baseline at Week 5 | -3.56 score on a scale | Standard Error 0.758 |
| Paroxetine 20 mg | Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS) | Baseline | 59.27 score on a scale | Standard Error 0.584 |
| Vortioxetine 10 mg | Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS) | Baseline | 58.56 score on a scale | Standard Error 0.578 |
| Vortioxetine 10 mg | Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS) | Change from Baseline at Week 5 | -0.82 score on a scale | Standard Error 0.752 |
| Vortioxetine 20 mg | Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS) | Baseline | 59.43 score on a scale | Standard Error 0.56 |
| Vortioxetine 20 mg | Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS) | Change from Baseline at Week 5 | -2.51 score on a scale | Standard Error 0.727 |
Comparison: ANCOVA with last observation carried forward (LOCF) model was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.00995% CI: [0.69, 4.78]ANCOVA with LOCF
Comparison: ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.30395% CI: [-0.95, 3.05]ANCOVA with LOCF
Primary
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1)
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.
Time frame: Baseline and Week 5
Population: mFAS1 included all participants in the FAS except those who had active drug concentrations below the limit of quantification (BLOQ) at all study visits where pharmacokinetic (PK) samples were collected.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Paroxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) | Baseline | 59.13 score on a scale | Standard Error 0.614 |
| Paroxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) | Change from Baseline at Week 5 | -4.01 score on a scale | Standard Error 0.803 |
| Vortioxetine 10 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) | Baseline | 58.55 score on a scale | Standard Error 0.582 |
| Vortioxetine 10 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) | Change from Baseline at Week 5 | -0.63 score on a scale | Standard Error 0.763 |
| Vortioxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) | Baseline | 59.36 score on a scale | Standard Error 0.576 |
| Vortioxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) | Change from Baseline at Week 5 | -2.38 score on a scale | Standard Error 0.754 |
Comparison: ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.00295% CI: [1.25, 5.51]ANCOVA with LOCF
Comparison: ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.12995% CI: [-0.47, 3.73]ANCOVA with LOCF
Primary
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2)
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.
Time frame: Baseline and Week 5
Population: mFAS2 included all participants in the FAS except those who had drug concentrations BLOQ at any study visit where PK samples were collected.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Paroxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) | Baseline | 58.73 score on a scale | Standard Error 0.675 |
| Paroxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) | Change from Baseline at Week 5 | -4.78 score on a scale | Standard Error 0.828 |
| Vortioxetine 10 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) | Baseline | 58.53 score on a scale | Standard Error 0.589 |
| Vortioxetine 10 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) | Change from Baseline at Week 5 | -0.47 score on a scale | Standard Error 0.724 |
| Vortioxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) | Baseline | 59.23 score on a scale | Standard Error 0.591 |
| Vortioxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) | Change from Baseline at Week 5 | -1.72 score on a scale | Standard Error 0.724 |
Comparison: ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: <0.00195% CI: [2.19, 6.43]ANCOVA with LOCF
Comparison: ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.00595% CI: [0.95, 5.17]ANCOVA with LOCF
Secondary
Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the 3 phases of the sexual response cycle , desire (5 items, score range 5-25), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.
Time frame: Baseline and Weeks 1, 2, 3, 4 and 5
Population: FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 4 | -0.11 score on a scale | Standard Error 0.181 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 2 | -0.34 score on a scale | Standard Error 0.175 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 5 | -0.42 score on a scale | Standard Error 0.325 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 5 | -0.12 score on a scale | Standard Error 0.206 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 1 | -0.01 score on a scale | Standard Error 0.136 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 4 | -0.14 score on a scale | Standard Error 0.194 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 2 | -0.40 score on a scale | Standard Error 0.26 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 1 | 0.09 score on a scale | Standard Error 0.225 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 3 | -0.20 score on a scale | Standard Error 0.176 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 2 | -0.21 score on a scale | Standard Error 0.158 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 3 | -0.22 score on a scale | Standard Error 0.182 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 1 | -0.12 score on a scale | Standard Error 0.13 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 5 | -0.19 score on a scale | Standard Error 0.195 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 4 | -0.36 score on a scale | Standard Error 0.297 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 3 | -0.50 score on a scale | Standard Error 0.286 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 4 | -1.07 score on a scale | Standard Error 0.307 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 1 | -0.50 score on a scale | Standard Error 0.234 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 2 | -0.83 score on a scale | Standard Error 0.269 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 3 | -1.09 score on a scale | Standard Error 0.296 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 5 | -1.38 score on a scale | Standard Error 0.336 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 1 | -0.30 score on a scale | Standard Error 0.141 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 2 | -0.47 score on a scale | Standard Error 0.181 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 3 | -0.43 score on a scale | Standard Error 0.188 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 4 | -0.54 score on a scale | Standard Error 0.187 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 5 | -0.67 score on a scale | Standard Error 0.202 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 1 | -0.48 score on a scale | Standard Error 0.135 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 2 | -0.61 score on a scale | Standard Error 0.164 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 3 | -0.75 score on a scale | Standard Error 0.183 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 4 | -1.04 score on a scale | Standard Error 0.201 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 5 | -1.09 score on a scale | Standard Error 0.214 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 3 | -0.08 score on a scale | Standard Error 0.186 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 4 | -0.37 score on a scale | Standard Error 0.304 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 5 | -0.42 score on a scale | Standard Error 0.211 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 4 | -0.10 score on a scale | Standard Error 0.185 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 4 | -0.45 score on a scale | Standard Error 0.199 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 5 | -0.03 score on a scale | Standard Error 0.2 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 3 | -0.22 score on a scale | Standard Error 0.293 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 1 | -0.22 score on a scale | Standard Error 0.134 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 1 | -0.23 score on a scale | Standard Error 0.232 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 2 | -0.26 score on a scale | Standard Error 0.162 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 2 | -0.34 score on a scale | Standard Error 0.266 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 5 | -0.19 score on a scale | Standard Error 0.333 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 3 | -0.33 score on a scale | Standard Error 0.18 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 1 | -0.05 score on a scale | Standard Error 0.14 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 2 | -0.35 score on a scale | Standard Error 0.179 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 2 | -0.30 score on a scale | Standard Error 0.174 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 3 | -0.51 score on a scale | Standard Error 0.18 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 1 | -0.03 score on a scale | Standard Error 0.135 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 2 | -0.37 score on a scale | Standard Error 0.157 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 4 | -0.77 score on a scale | Standard Error 0.294 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 4 | -0.54 score on a scale | Standard Error 0.179 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 3 | -0.77 score on a scale | Standard Error 0.284 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 5 | -0.79 score on a scale | Standard Error 0.204 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 5 | -0.82 score on a scale | Standard Error 0.322 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Arousal Score: Week 5 | -0.54 score on a scale | Standard Error 0.193 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 3 | -0.67 score on a scale | Standard Error 0.175 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 4 | -0.72 score on a scale | Standard Error 0.192 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 1 | -0.14 score on a scale | Standard Error 0.223 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 1 | -0.15 score on a scale | Standard Error 0.129 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5 | Desire Score: Week 2 | -0.68 score on a scale | Standard Error 0.258 |
Secondary
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the subscales of pleasure (1 item, score range 1-5), desire/frequency (2 items, score range 2-10), desire/interest (3 items, score range 3-15), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.
Time frame: Baseline and Weeks 1, 2, 3, 4 and 5
Population: FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 2 | -0.30 score on a scale | Standard Error 0.118 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 2 | -0.21 score on a scale | Standard Error 0.158 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 4 | -0.11 score on a scale | Standard Error 0.2 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 3 | -0.16 score on a scale | Standard Error 0.193 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 3 | -0.33 score on a scale | Standard Error 0.128 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 4 | -0.11 score on a scale | Standard Error 0.181 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 2 | -0.09 score on a scale | Standard Error 0.181 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 1 | -0.07 score on a scale | Standard Error 0.064 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 4 | -0.25 score on a scale | Standard Error 0.126 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 1 | -0.03 score on a scale | Standard Error 0.097 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 1 | 0.12 score on a scale | Standard Error 0.162 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 3 | -0.23 score on a scale | Standard Error 0.085 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 5 | -0.28 score on a scale | Standard Error 0.141 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 3 | -0.20 score on a scale | Standard Error 0.176 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 5 | -0.21 score on a scale | Standard Error 0.086 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 2 | -0.34 score on a scale | Standard Error 0.175 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 1 | -0.12 score on a scale | Standard Error 0.13 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 4 | -0.14 score on a scale | Standard Error 0.194 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 5 | -0.19 score on a scale | Standard Error 0.195 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 1 | -0.01 score on a scale | Standard Error 0.136 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 5 | -0.14 score on a scale | Standard Error 0.215 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 5 | -0.12 score on a scale | Standard Error 0.206 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 3 | -0.22 score on a scale | Standard Error 0.182 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 4 | -0.18 score on a scale | Standard Error 0.085 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 2 | -0.26 score on a scale | Standard Error 0.079 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 4 | -1.04 score on a scale | Standard Error 0.201 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 5 | -0.67 score on a scale | Standard Error 0.202 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 1 | -0.48 score on a scale | Standard Error 0.135 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 2 | -0.61 score on a scale | Standard Error 0.164 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 3 | -0.75 score on a scale | Standard Error 0.183 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 1 | -0.35 score on a scale | Standard Error 0.1 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 5 | -0.47 score on a scale | Standard Error 0.089 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 5 | -1.09 score on a scale | Standard Error 0.214 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 2 | -0.38 score on a scale | Standard Error 0.082 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 2 | -0.46 score on a scale | Standard Error 0.122 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 3 | -0.62 score on a scale | Standard Error 0.132 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 1 | -0.36 score on a scale | Standard Error 0.066 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 4 | -0.55 score on a scale | Standard Error 0.13 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 5 | -0.66 score on a scale | Standard Error 0.145 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 1 | -0.15 score on a scale | Standard Error 0.169 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 3 | -0.44 score on a scale | Standard Error 0.088 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 2 | -0.38 score on a scale | Standard Error 0.186 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 3 | -0.47 score on a scale | Standard Error 0.2 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 4 | -0.52 score on a scale | Standard Error 0.206 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 5 | -0.73 score on a scale | Standard Error 0.223 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 4 | -0.38 score on a scale | Standard Error 0.088 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 1 | -0.30 score on a scale | Standard Error 0.141 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 2 | -0.47 score on a scale | Standard Error 0.181 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 3 | -0.43 score on a scale | Standard Error 0.188 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 4 | -0.54 score on a scale | Standard Error 0.187 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 3 | -0.01 score on a scale | Standard Error 0.198 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 1 | -0.13 score on a scale | Standard Error 0.065 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 2 | -0.25 score on a scale | Standard Error 0.12 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 1 | -0.22 score on a scale | Standard Error 0.134 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 4 | -0.18 score on a scale | Standard Error 0.204 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 5 | -0.42 score on a scale | Standard Error 0.211 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 1 | -0.07 score on a scale | Standard Error 0.099 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 4 | -0.10 score on a scale | Standard Error 0.185 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 5 | -0.05 score on a scale | Standard Error 0.221 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 3 | -0.08 score on a scale | Standard Error 0.186 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 4 | -0.45 score on a scale | Standard Error 0.199 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 5 | -0.16 score on a scale | Standard Error 0.088 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 1 | -0.05 score on a scale | Standard Error 0.14 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 4 | -0.31 score on a scale | Standard Error 0.087 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 5 | -0.15 score on a scale | Standard Error 0.144 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 4 | -0.20 score on a scale | Standard Error 0.129 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 3 | -0.33 score on a scale | Standard Error 0.18 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 1 | -0.16 score on a scale | Standard Error 0.167 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 5 | -0.03 score on a scale | Standard Error 0.2 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 3 | -0.23 score on a scale | Standard Error 0.131 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 2 | -0.35 score on a scale | Standard Error 0.179 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 2 | -0.11 score on a scale | Standard Error 0.185 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 3 | -0.18 score on a scale | Standard Error 0.087 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 2 | -0.25 score on a scale | Standard Error 0.081 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 2 | -0.26 score on a scale | Standard Error 0.162 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 5 | -0.79 score on a scale | Standard Error 0.204 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 1 | -0.15 score on a scale | Standard Error 0.063 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 2 | -0.26 score on a scale | Standard Error 0.078 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 3 | -0.42 score on a scale | Standard Error 0.084 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 4 | -0.37 score on a scale | Standard Error 0.084 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Pleasure Score: Week 5 | -0.33 score on a scale | Standard Error 0.085 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 1 | -0.23 score on a scale | Standard Error 0.096 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 2 | -0.46 score on a scale | Standard Error 0.116 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 3 | -0.50 score on a scale | Standard Error 0.127 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 4 | -0.43 score on a scale | Standard Error 0.125 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 1 | 0.09 score on a scale | Standard Error 0.161 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 2 | -0.22 score on a scale | Standard Error 0.179 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 3 | -0.28 score on a scale | Standard Error 0.191 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 4 | -0.35 score on a scale | Standard Error 0.198 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Interest Score: Week 5 | -0.33 score on a scale | Standard Error 0.213 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 1 | -0.03 score on a scale | Standard Error 0.135 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 2 | -0.30 score on a scale | Standard Error 0.174 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 3 | -0.51 score on a scale | Standard Error 0.18 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 4 | -0.54 score on a scale | Standard Error 0.179 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Arousal/Excitement/Erection Score: Week 5 | -0.54 score on a scale | Standard Error 0.193 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 1 | -0.15 score on a scale | Standard Error 0.129 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 2 | -0.37 score on a scale | Standard Error 0.157 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 3 | -0.67 score on a scale | Standard Error 0.175 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Orgasm/Completion/Ejaculation Score: Week 4 | -0.72 score on a scale | Standard Error 0.192 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 | Desire/Frequency Score: Week 5 | -0.49 score on a scale | Standard Error 0.139 |
Secondary
Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.
Time frame: Baseline and Weeks 1, 2, 3, 4 and 5
Population: FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Here, number analyzed are the participants who were evaluated for this outcome measure in the FAS.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 2 | -1.11 score on a scale | Standard Error 0.598 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 4 | -0.62 score on a scale | Standard Error 0.666 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 3 | -0.91 score on a scale | Standard Error 0.639 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 5 | -0.79 score on a scale | Standard Error 0.734 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 1 | -0.05 score on a scale | Standard Error 0.44 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 5 | -3.56 score on a scale | Standard Error 0.758 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 1 | -1.67 score on a scale | Standard Error 0.457 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 2 | -2.40 score on a scale | Standard Error 0.617 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 3 | -2.77 score on a scale | Standard Error 0.661 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 4 | -3.11 score on a scale | Standard Error 0.688 |
Comparison: Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.12395% CI: [-2.93, 0.35]ANCOVA with LOCF
Comparison: Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.00995% CI: [-2.84, -0.41]ANCOVA with LOCF
Comparison: Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.03995% CI: [-3.61, -0.1]ANCOVA with LOCF
Comparison: Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.00895% CI: [-4.32, -0.66]ANCOVA with LOCF
Comparison: Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.00795% CI: [-4.78, -0.75]ANCOVA with LOCF
Secondary
Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.
Time frame: Baseline and Weeks 1, 2, 3, 4 and 5
Population: FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Here, number analyzed are the participants who were evaluated for this outcome measure in the FAS.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 4 | -0.62 score on a scale | Standard Error 0.666 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 3 | -0.91 score on a scale | Standard Error 0.639 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 1 | -0.05 score on a scale | Standard Error 0.44 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 2 | -1.11 score on a scale | Standard Error 0.598 |
| Paroxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 5 | -0.79 score on a scale | Standard Error 0.734 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 3 | -0.77 score on a scale | Standard Error 0.655 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 1 | -0.54 score on a scale | Standard Error 0.453 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 2 | -1.18 score on a scale | Standard Error 0.612 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 4 | -1.20 score on a scale | Standard Error 0.683 |
| Vortioxetine 10 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 5 | -0.82 score on a scale | Standard Error 0.752 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 5 | -2.51 score on a scale | Standard Error 0.727 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 4 | -2.43 score on a scale | Standard Error 0.659 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 1 | -0.38 score on a scale | Standard Error 0.436 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 3 | -2.36 score on a scale | Standard Error 0.633 |
| Vortioxetine 20 mg | Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 | Week 2 | -1.55 score on a scale | Standard Error 0.592 |
Comparison: Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.41995% CI: [-1.7, 0.71]ANCOVA with LOCF
Comparison: Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.58195% CI: [-1.51, 0.85]ANCOVA with LOCF
Comparison: Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.93895% CI: [-1.69, 1.56]ANCOVA with LOCF
Comparison: Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.59295% CI: [-2.04, 1.17]ANCOVA with LOCF
Comparison: Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.8795% CI: [-1.6, 1.89]ANCOVA with LOCF
Comparison: Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.09895% CI: [-3.16, 0.27]ANCOVA with LOCF
Comparison: Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.53295% CI: [-2.39, 1.24]ANCOVA with LOCF
Comparison: Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.04695% CI: [-3.6, -0.03]ANCOVA with LOCF
Comparison: Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.97795% CI: [-2.03, 1.97]ANCOVA with LOCF
Comparison: Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.08795% CI: [-3.68, 0.25]ANCOVA with LOCF
Secondary
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4
The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.
Time frame: Baseline and Weeks 1, 2, 3 and 4
Population: FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Here, number analyzed are the participants who were evaluated for this outcome measure in the FAS.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Paroxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Week 3 | -2.77 score on a scale | Standard Error 0.661 |
| Paroxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Week 1 | -1.67 score on a scale | Standard Error 0.457 |
| Paroxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Week 4 | -3.11 score on a scale | Standard Error 0.688 |
| Paroxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Week 2 | -2.40 score on a scale | Standard Error 0.617 |
| Vortioxetine 10 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Week 3 | -0.77 score on a scale | Standard Error 0.655 |
| Vortioxetine 10 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Week 2 | -1.18 score on a scale | Standard Error 0.612 |
| Vortioxetine 10 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Week 4 | -1.20 score on a scale | Standard Error 0.683 |
| Vortioxetine 10 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Week 1 | -0.54 score on a scale | Standard Error 0.453 |
| Vortioxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Week 4 | -2.43 score on a scale | Standard Error 0.659 |
| Vortioxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Week 1 | -0.38 score on a scale | Standard Error 0.436 |
| Vortioxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Week 2 | -1.55 score on a scale | Standard Error 0.592 |
| Vortioxetine 20 mg | Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 | Week 3 | -2.36 score on a scale | Standard Error 0.633 |
Comparison: Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.07295% CI: [-0.1, 2.37]ANCOVA with LOCF
Comparison: Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.03595% CI: [0.09, 2.5]ANCOVA with LOCF
Comparison: Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.14995% CI: [-0.44, 2.89]ANCOVA with LOCF
Comparison: Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.30395% CI: [-0.78, 2.48]ANCOVA with LOCF
Comparison: Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.02895% CI: [0.22, 3.78]ANCOVA with LOCF
Comparison: Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.64595% CI: [-1.33, 2.15]ANCOVA with LOCF
Comparison: Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.04395% CI: [0.06, 3.77]ANCOVA with LOCF
Comparison: Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.p-value: 0.46595% CI: [-1.14, 2.49]ANCOVA with LOCF
Secondary
Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5
Sexual dysfunction is defined as CSFQ-14 score ≤47 for men and ≤41 for women.
Time frame: Weeks 1, 2, 3, 4 and 5
Population: FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paroxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 4 | 4.5 percentage of participants |
| Paroxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 2 | 7.9 percentage of participants |
| Paroxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 5 | 3.4 percentage of participants |
| Paroxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 3 | 4.5 percentage of participants |
| Paroxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 1 | 2.2 percentage of participants |
| Vortioxetine 10 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 3 | 8.4 percentage of participants |
| Vortioxetine 10 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 4 | 9.6 percentage of participants |
| Vortioxetine 10 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 5 | 9.6 percentage of participants |
| Vortioxetine 10 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 2 | 8.4 percentage of participants |
| Vortioxetine 10 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 1 | 2.4 percentage of participants |
| Vortioxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 3 | 3.5 percentage of participants |
| Vortioxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 1 | 1.2 percentage of participants |
| Vortioxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 2 | 3.5 percentage of participants |
| Vortioxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 4 | 4.7 percentage of participants |
| Vortioxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 5 | 5.9 percentage of participants |
| Vortioxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 4 | 7.7 percentage of participants |
| Vortioxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 2 | 2.2 percentage of participants |
| Vortioxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 1 | 1.1 percentage of participants |
| Vortioxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 3 | 6.6 percentage of participants |
| Vortioxetine 20 mg | Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 | Week 5 | 9.9 percentage of participants |
Comparison: Week 2p-value: 0.25695% CI: [0.107, 1.814]Regression, Logistic
Comparison: Week 2p-value: 0.15495% CI: [0.059, 1.561]Regression, Logistic
Comparison: Week 3p-value: 0.1695% CI: [0.087, 1.497]Regression, Logistic
Comparison: Week 1p-value: 0.51595% CI: [0.037, 5.201]Regression, Logistic
Comparison: Week 1p-value: 0.67795% CI: [0.049, 7.051]Regression, Logistic
Comparison: Week 1p-value: 0.7295% CI: [0.181, 11.912]Regression, Logistic
Comparison: Week 1p-value: 0.73295% CI: [0.053, 7.861]Regression, Logistic
Comparison: Week 1p-value: 0.91395% CI: [0.066, 11.303]Regression, Logistic
Comparison: Week 2p-value: 0.16495% CI: [0.09, 1.507]Regression, Logistic
Comparison: Week 2p-value: 0.09895% CI: [0.05, 1.287]Regression, Logistic
Comparison: Week 2p-value: 0.75895% CI: [0.383, 3.731]Regression, Logistic
Comparison: Week 3p-value: 0.74495% CI: [0.252, 2.679]Regression, Logistic
Comparison: Week 3p-value: 0.19495% CI: [0.636, 9.317]Regression, Logistic
Comparison: Week 3p-value: 0.87195% CI: [0.181, 4.261]Regression, Logistic
Comparison: Week 3p-value: 0.32995% CI: [0.497, 8.037]Regression, Logistic
Comparison: Week 4p-value: 0.18795% CI: [0.119, 1.514]Regression, Logistic
Comparison: Week 4p-value: 0.72995% CI: [0.273, 2.476]Regression, Logistic
Comparison: Week 4p-value: 0.13395% CI: [0.739, 9.917]Regression, Logistic
Comparison: Week 4p-value: 0.85295% CI: [0.266, 4.961]Regression, Logistic
Comparison: Week 4p-value: 0.2495% CI: [0.585, 8.472]Regression, Logistic
Comparison: Week 5p-value: 0.31795% CI: [0.166, 1.789]Regression, Logistic
Comparison: Week 5p-value: 0.7995% CI: [0.41, 3.233]Regression, Logistic
Comparison: Week 5p-value: 0.07395% CI: [0.888, 14.911]Regression, Logistic
Comparison: Week 5p-value: 0.37195% CI: [0.442, 8.902]Regression, Logistic
Comparison: Week 5p-value: 0.04695% CI: [1.027, 17.063]Regression, Logistic